510(k) K173192 ยท GWM Device, Monitoring, Intracranial Pressure
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
| Applicant | Codman & Shurtleff, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Nov 8, 2017 |
| Received | Oct 2, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173192
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2026 | Integra LifeSciences Corp. (NeuroSciences) Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850.
The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The I Open, Classified |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.